Finacea (Azelaic Acid) - Indications and Dosage

INDICATIONS AND USAGE

FINACEA Gel, 15%, is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. Patients should be instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages and to use only very mild soaps or soapless cleansing lotion for facial cleansing.

DOSAGE AND ADMINISTRATION

A thin layer of FINACEA Gel, 15%, should be gently massaged into the affected areas on the face twice daily, in the morning and evening. Patients should be reassessed if no improvement is observed upon completing 12 weeks of therapy.

HOW SUPPLIED

FINACEA® Gel, 15%, is supplied in tubes in the following size:

50 g - NDC 10922-825-02

Storage

Store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) [See USP Controlled Room Temperature].

Distributed under license; U.S. Patent No 4,713,394

© 2005, Intendis, Inc. All rights reserved.

May 2005

Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy

Distributed by: INTENDIS Pine Brook, NJ 07058

6058301 2540870